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| ID | Type | Description | Link |
|---|---|---|---|
| 1R03HD120509-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | NIH |
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The purpose of this study is to evaluate a new virtual reality (VR)-based rehabilitation program designed to help stroke survivors improve their walking abilities in real-world settings. By comparing immersive VR-assisted overground gait therapy to contemporary non-immersive, treadmill-based VR therapy (i.e., C-Mill), the investigators aim to determine its effectiveness in enhancing mobility and quality of life for stroke survivors.
After obtaining consent and screening, eligible participants are randomized to the treatment or control groups.
First, all participants are issued a wearable tracker to gauge baseline activity for at least 5 days.
During the intervention phase, participants undergo 12 treatment sessions, 2x a week for 6 weeks.
Assessments are conducted at pre-intervention, post-intervention, and 1-month followup.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| VR-Assisted Overground Gait Therapy | Experimental | Participants in the treatment group (VG-AOGT) will engage in gait training within a newly developed immersive virtual reality (VR) environment. This setup features self-propelled overground walking influenced by three different virtual environments designed to mimic real-world conditions. The immersive technology used is HTC VIVE Focus Vision, enabling participants to practice walking in real-world environments and gait tasks. |
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| Conventional Treadmill-Based VR Gait Therapy | Active Comparator | Participants in the control group (VR-CTGT) will engage in gait training using C-Mill VR+ technology, which involves treadmill-assisted walking on a treadmill while interacting with less immersive virtual scenarios presented on screens. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Walk-over-Ground | Device | Fully-immersive, real-world environments, overground gait therapy |
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| Measure | Description | Time Frame |
|---|---|---|
| Step Count | FitBit tracks the number of steps (count) taken by participant. | Continuous tracking from Screening to Week 10 |
| Travel Distance | FitBit tracks the total distance (miles) travelled by participant. | Continuous tracking from Screening to Week 10 |
| Activity Zone Minutes | Fitbit calculates maximum heart rate (HR) from user age (Max HR = 220 - age) and defines Activity Zone thresholds based on percentages of max HR (Fat Burn 50-69%, Cardio/Peak >70%). Activity Zone Minutes (AZMs) are an intensity-weighted measure of activity. AZM (count) is based on sustained heart rate over time: 1 AZM per minute in the Fat Burn Zone (50-69% max HR) and 2 AZMs per minute in the Cardio/Peak Zones (>=70% max HR). | Continuous tracking from Screening to Week 10 |
| Measure | Description | Time Frame |
|---|---|---|
| 10-Meter Walk Test | 10MWT: Subjects will walk a distance of 10 meters at their normal pace while being timed, allowing assessment of gait speed and mobility. | Baseline, Week 7, Week 10 |
| 6-Minute Walk Test |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of Life after Brain Injury | Participants will complete the Quality of Life after Brain Injury questionnaire assessing the health-related quality of life specifically tailored for individuals recovering from brain injury. The questionnaire includes 37 items. Scores range from 0 to 100, with 0 indicating the worst possible quality of life and 100 indicating the best possible quality of life; higher scores indicate better health-related quality of life. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Peter Altenburger, Ph.D., PT | Contact | 317-278-0703 | paltenbu@iu.edu | |
| Hee-Tae Jung, Ph.D. | Contact | 317-278-1285 | heetjung@iu.edu |
| Name | Affiliation | Role |
|---|---|---|
| Hee-Tae Jung, Ph.D. | Indiana University, Luddy School of Informatics, Computing, and Engineering | Principal Investigator |
| Peter Altenburger, Ph.D., PT | Indiana University, School of Health & Human Sciences; Indiana University Health, Center for Advanced Neurorehabilitation |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Indiana University Health, Neurorehabilitation & Robotics | Recruiting | Indianapolis | Indiana | 46202 | United States |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| C-Mill VR+ by Motek | Device | Semi-immersive, game-like environments, treadmill gait therapy |
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6MWT: Subjects will walk for 6 minutes along a 30m track. Subjects may stop and rest as often as needed. Subject walking speed will be collected during the test to evaluate the rate of functional fatigue.
| Baseline, Week 7, Week 10 |
| Dynamic Gait Index | DGI: Subjects will complete 14 different tasks ranging from static standing to dynamic walking. All subjects will be guarded closely for safety to prevent falling. | Baseline, Week 7, Week 10 |
| Timed Up and Go Test | TUG: Subjects will rise from a seated position, walk three meters, turn around, walk back to the chair, and sit down. This test is used to assess mobility, balance, walking ability, and fall risk. | Baseline, Week 7, Week 10 |
| Step-Over Test | SOT: Patients will walk over a flat firm surface for 14 meters. The pathway will include a box that is one foot wide. Each participant will complete 10 passes, stepping over the obstacle (box) each time. | Baseline, Week 7, Week 10 |
| Step Length | With the PKMAS Zeno Walkway (ProtoKinetics), participants walk over a 14-foot pressure mat to capture gait kinematics. Step length (centimeters) measures the distance between the heel contact point of one foot to the heel contact point of the other foot. | Baseline, Week 7, Week 10 |
| Stride Length | With the PKMAS Zeno Walkway (ProtoKinetics), participants walk over a 14-foot pressure mat to capture gait kinematics. Stride length (centimeters) measures the distance between successive heel contact points of the same foot. | Baseline, Week 7, Week 10 |
| Stance Percentage | With the PKMAS Zeno Walkway (ProtoKinetics), participants walk over a 14-foot pressure mat to capture gait kinematics. During the gait cycle, each foot alternates between being in contact with the ground (stance phase) and not in contact with the ground (swing phase). Stance percentage (percent) is the proportion of the gait cycle during which a foot remains in the stance phase. | Baseline, Week 7, Week 10 |
| Gait Speed | With the PKMAS Zeno Walkway (ProtoKinetics), participants walk over a 14-foot pressure mat to capture gait kinematics. Gait speed (meters per second) is calculated by dividing the distance walked (meters) by the time taken (seconds). | Baseline, Week 7, Week 10 |
| Baseline, Week 7, Week 10 |
| Disability Rating Scale | Participants will complete the Disability Rating Scale questionnaire assessing the level of disability and functional impairment. The scale includes 8 items. Scores range from 0 to 29, with 0 indicating no disability and 29 indicating extreme vegetative state; higher scores indicate greater disability and functional impairment. | Baseline, Week 7, Week 10 |
| Cybersickness in Virtual Reality Questionnaire | Participants will complete the Cybersickness in Virtual Reality Questionnaire assessing physical symptoms associated with VR exposure, including nausea, dizziness, disorientation, imbalance, fatigue, and visual discomfort. The questionnaire includes 6 items rated from 1 to 7. Scores range from 6 to 42; higher scores indicate greater cybersickness symptom intensity. | Week 1, Week 4, Week 6 |
| Igroup Presence Questionnaire | Participants will complete the Igroup Presence Questionnaire measuring the user's sense of presence and immersion in VR, such as perceived realism and awareness. The questionnaire includes 14 items using a 7-point Likert scale ranging from -3 to +3. Negatively worded items will be reverse-scored. Scores range from -42 to +42; higher scores indicate greater perceived presence. | Week 1, Week 4, Week 6 |
| Perceived Walking Experience Questionnaire | Participants will complete the Perceived Walking Experience Questionnaire, which compares walking in VR with real-world walking in terms of comfort, gait differences, headset-related limitation, and safety concerns. The questionnaire includes 5 items rated from 1 to 5. Scores range from 5 to 25; higher scores indicate a less favorable perceived VR walking experience in relation to real-world walking. This questionnaire is adapted from Horsak et al. (2021), "Overground Walking in a Fully Immersive Virtual Reality." | Week 1, Week 4, Week 6 |
| Virtual Reality System Usability Questionnaire | Participants will complete the Virtual Reality System Usability Questionnaire assessing the usability of the VR system, including responsiveness, clarity, learnability, enjoyment, errors, adverse symptoms, and mental burden. The questionnaire includes 9 items rated from 1 to 5. Negatively worded items will be reverse-scored. Scores range from 9 to 45; higher scores indicate greater perceived VR system usability. | Week 1, Week 4, Week 6 |
| NASA Task Load Index | Participants will complete the National Aeronautics and Space Administration Task Load Index measuring perceived task workload across mental demand, physical demand, temporal demand, performance, effort, and frustration. The questionnaire includes 6 items. Scores range from 0 to 100; higher scores indicate greater perceived workload. | Week 1, Week 4, Week 6 |
| Interview | Participants will take part in 30-minute semi-structured interviews to share their thoughts on the user experience (e.g. engagement, utility, realism) and provide feedback to improve the virtual reality system. | Week 1, Week 4, Week 6 |
| Principal Investigator |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |